BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1120749 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04961
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    June 4, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO DAYS AFTER IMPLANT, THE PT COMPLAINT OF STIMULATION DOWN THE RIGHT LEG THAT CAUSED TWITCHING WHEN THE PT TRIED TO USE THE DEVICE. THE STIMULATION WAS PAINFUL AND THE PT TURNED THE DEVICE DOWN. AN X-RAY REVEALED THE LEAD WAS AT THE S3 FORAMEN. A LEAD REVISION WAS PERFORMED. NO SURGICAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention EXPLANTED| IMPLANTED| LEAD MODEL 3093 LOT # V102868